Expandable Intervertebral Implant

ABSTRACT

An intervertebral implant is configured to be implanted in an intervertebral space in a first initial configuration. Subsequently, an actuator is configured to be driven in an actuation direction such that the actuator urges the implant to expand along a first expansion direction. Once the implant has been fully expanded along the first expansion direction, the actuator is configured to be further driven in the actuation direction so as to expand the implant in a second expansion direction that is perpendicular to the first expansion direction.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation of U.S. patent application Ser. No. 16/842,058 filed Apr. 7, 2020, which claims priority to U.S. Patent Application Ser. No. 62/986,156 filed Mar. 6, 2020, the disclosure of which is hereby incorporated by reference as if set forth in its entirety herein.

BACKGROUND 1. Field

The present disclosure relates to orthopedic implantable devices, and more particularly implantable devices for stabilizing the spine. Even more particularly, the present disclosure is directed to expandable, angularly adjustable intervertebral cages comprising articulating mechanisms that allow expansion from a first, insertion configuration having a reduced size to a second, implanted configuration having an expanded size. The intervertebral cages are configured to adjust and adapt to lodortic angles, particularly larger lodortic angles, while restoring sagittal balance and alignment of the spine.

2. Description of the Related Art

The use of fusion-promoting interbody implantable devices, often referred to as cages or spacers, is well known as the standard of care for the treatment of certain spinal disorders or diseases. For example, in one type of spinal disorder, the intervertebral disc has deteriorated or become damaged due to acute injury or trauma, disc disease or simply the natural aging process. A healthy intervertebral disc serves to stabilize the spine and distribute forces between vertebrae, as well as cushion the vertebral bodies. A weakened or damaged disc therefore results in an imbalance of forces and instability of the spine, resulting in discomfort and pain. A typical treatment may involve surgical removal of a portion or all of the diseased or damaged intervertebral disc in a process known as a partial or total discectomy, respectively. The discectomy is often followed by the insertion of a cage or spacer to stabilize this weakened or damaged spinal region. This cage or spacer serves to reduce or inhibit mobility in the treated area, in order to avoid further progression of the damage and/or to reduce or alleviate pain caused by the damage or injury. Moreover, these type of cages or spacers serve as mechanical or structural scaffolds to restore and maintain normal disc height, and in some cases, can also promote bony fusion between the adjacent vertebrae.

However, one of the current challenges of these types of procedures is the very limited working space afforded the surgeon to manipulate and insert the cage into the intervertebral area to be treated. Access to the intervertebral space requires navigation around retracted adjacent vessels and tissues such as the aorta, vena cava, dura and nerve roots, leaving a very narrow pathway for access. The opening to the intradiscal space itself is also relatively small. Hence, there are physical limitations on the actual size of the cage that can be inserted without significantly disrupting the surrounding tissue or the vertebral bodies themselves.

Further complicating the issue is the fact that the vertebral bodies are not positioned parallel to one another in a normal spine. There is a natural curvature to the spine due to the angular relationship of the vertebral bodies relative to one another. The ideal cage must be able to accommodate this angular relationship of the vertebral bodies, or else the cage will not sit properly when inside the intervertebral space. An improperly fitted cage would either become dislodged or migrate out of position, and lose effectiveness over time, or worse, further damage the already weakened area.

Thus, it is desirable to provide intervertebral cages or spacers that not only have the mechanical strength or structural integrity to restore disc height or vertebral alignment to the spinal segment to be treated, but also be configured to easily pass through the narrow access pathway into the intervertebral space, and then accommodate the angular constraints of this space, particularly for larger lodortic angles.

SUMMARY

In one example, an intervertebral implant can include an implant body that defines a superior body configured to face a superior vertebra, and an inferior body configured to face an inferior vertebra. The implant can further include an actuator supported by the implant body, the actuator movable in the implant body from an initial position to a first expansion position, and subsequently from the first expansion position to a second expansion position. Movement of the actuator from the initial position to the first expansion position causes the actuator to urge the implant body to expand along a first direction of expansion, and movement of the actuator from the first expansion position to the second expansion position causes the actuator to urge the implant body to expand along a second direction of expansion that is perpendicular to the first direction of expansion.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing summary, as well as the following detailed description of illustrative embodiments of the present application, will be better understood when read in conjunction with the appended drawings. For the purposes of illustrating the locking structures of the present application, there is shown in the drawings illustrative embodiments. It should be understood, however, that the application is not limited to the precise arrangements and instrumentalities shown. In the drawings:

FIG. 1A shows a pair of intervertebral implants inserted into an intervertebral space in a first insertion configuration;

FIG. 1B shows the intervertebral implants of FIG. 1A expanded along a first direction of expansion;

FIG. 1C shows the intervertebral implants of FIG. 1B further expanded along a second direction of expansion;

FIG. 2A is a first perspective view of an implant body of the pair of intervertebral implants illustrated in FIG. 1A;

FIG. 2B is a second perspective view of the implant body illustrated in FIG. 2A;

FIG. 3A is an exploded perspective view of an intervertebral implant of the pair of intervertebral implants illustrated in FIG. 1A;

FIG. 3B is a cross-sectional perspective view of the intervertebral implant illustrated in FIG. 3A;

FIG. 3C is an exploded sectional side elevation view of the intervertebral implant illustrated in FIG. 3A;

FIG. 4A is a sectional side elevation view of the intervertebral implant illustrated in FIG. 3A, showing the implant in a first or initial configuration;

FIG. 4B is a sectional side elevation view of the intervertebral implant of FIG. 4A, but showing the implant expanded along a first direction of expansion;

FIG. 5A is another sectional side elevation view of the intervertebral implant illustrated in FIG. 4B;

FIG. 5B is a side elevation view of the intervertebral implant illustrated in FIG. 5A, showing the implant expanded along a second direction of expansion;

FIG. 5C is a side elevation view of the intervertebral implant illustrated in FIG. 5B, showing the implant further expanded along the second direction of expansion;

FIG. 6A is an exploded perspective view of a portion of the intervertebral implant of FIG. 3A, showing a locking assembly constructed in accordance with one embodiment; and

FIG. 6B is an exploded perspective view of the portion of the intervertebral implant of FIG. 6A, showing the locking assembly in a locked configuration.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The present disclosure provides various spinal or intervertebral implants, such as interbody fusion spacers, or cages, for insertion between adjacent vertebrae. The devices can be configured for use in either the cervical or lumbar region of the spine. In some embodiments, these devices are configured as PLIF cages, or posterior lumbar interbody fusion cages. These cages can restore and maintain intervertebral height of the spinal segment to be treated, and stabilize the spine by restoring sagittal balance and alignment. In some embodiments, the cages may contain an articulating mechanism to allow expansion and angular adjustment. This articulating mechanism allows upper and lower plate components to glide smoothly relative to one another.

As illustrated in FIG. 1A, one or more intervertebral implants 20 can be inserted into an intervertebral space 22 in a first, insertion configuration characterized by a first reduced size its insertion end to facilitate insertion through a narrow access passage. The one or more intervertebral implants 20 can be inserted in a PLIF approach into the intervertebral space. However, it is recognized that the one or more intervertebral implants 20 can be inserted along any suitable approach as desired. While a pair of intervertebral implants 20 are shown inserted into the intervertebral space, it is also appreciated that a single implant can be inserted into the intervertebral space having any suitable size and shape as desired. The intervertebral space 22 is defined by a superior vertebra 24 and an inferior vertebra 26 that are spaced from each other along a transverse direction T, which defines a cranial-caudal direction when the intervertebral implant 20 is disposed in the intervertebral space 22. As described herein, structure, elements, devices, and method steps described in the plural applies with equal force and effect to the singular unless otherwise indicated. For instance, while a pair of intervertebral implants 20 are illustrated as implanted in the intervertebral space 22 in FIG. 1A, it is appreciated that a single intervertebral implant 20 can alternatively be implanted in the intervertebral space 22. Conversely, as described herein, structure, elements, devices, and method steps described in the singular applies with equal force and effect to the plural unless otherwise indicated.

The intervertebral implants 20 may be inserted having the first reduced size as illustrated in FIG. 1A, and then expanded to a second, expanded configuration having an expanded size once implanted, as illustrated in FIGS. 1B and 1C. The second expanded size is greater than the first reduced size in at least one direction. In some embodiments, the second expanded size is greater than the first reduced size along two perpendicular directions that are each perpendicular to the direction of insertion. In their second expanded configuration, the cages are able to maintain the proper disc height and stabilize the spine by restoring sagittal balance and alignment.

For instance, as illustrated in FIG. 1B, the second expanded configuration can include a first expansion in a lateral direction A that is oriented perpendicular to the transverse direction T. In particular, the intervertebral implant 20 can expand in a first direction of expansion to achieve the first expansion along the lateral direction A. Thus, the first direction of expansion can be along the lateral direction A. That is, the implant has a first width along the lateral direction A in the first reduced size, and a second width along the lateral direction A in the second expanded size that is greater than the first width.

Further, as illustrated in FIG. 1C, the second expanded configuration can include a second expansion in a transverse direction T. In particular, the intervertebral implant 20 can expand in a second direction of expansion to achieve the second expansion along the transverse direction T. Thus, the second direction of expansion can be along the transverse direction T.

As described in more detail below, the intervertebral implant 20 can expand only along the first direction of expansion without expanding in the second direction of expansion. Subsequently, the intervertebral implant can expand only along the second direction of expansion without expanding in the first direction of expansion. In some examples, the implant can simultaneously expand along both the first and second directions of expansion after expanding only along the first direction of expansion and prior to expanding only along the second direction of expansion. Further, in some examples the intervertebral implant 20 can be expandable in the second direction of expansion only after expansion in the first direction of expansion has been completed.

It is contemplated that, in some embodiments, the intervertebral implant 20 may also be designed to expand in either or both of the first and second directions of expansion in a freely selectable (or stepless) manner to reach its second expanded configuration. The intervertebral implant 20 can further be configured to be able to adjust the angle of lordosis, and can accommodate larger lodortic angles in its second expanded configuration. Further, the intervertebral implant 20 may promote fusion to further enhance spine stability by immobilizing the adjacent vertebral bodies.

Additionally, the intervertebral implant 20 may be manufactured using selective laser melting (SLM) techniques, a form of additive manufacturing. The intervertebral implant 20 may also be manufactured by other comparable techniques, such as for example, 3D printing, electron beam melting (EBM), layer deposition, and rapid manufacturing. With these production techniques, it is possible to create an all-in-one, multi-component device which may have interconnected and movable parts without further need for external fixation or attachment elements to keep the components together. Accordingly, the intervertebral implant 20 disclosed herein can be formed of multiple, interconnected parts that do not require additional external fixation elements to keep together.

The intervertebral implant 20 manufactured in this manner does not have connection seams in some examples, whereas devices traditionally manufactured would have joined seams to connect one component to another. These connection seams can often represent weakened areas of traditionally manufactured implantable devices, particularly when the bonds of these seams wear or break over time with repeated use or under stress. By manufacturing the present intervertebral implant 20 using additive manufacturing, connection seams are avoided entirely and therefore the problem is avoided.

In addition, by manufacturing the intervertebral implant 20 using an additive manufacturing process, all of the components of the intervertebral implant 20 (including both an implant body and an actuator that is configured to expand the implant body as described below) remain a complete construct during both the insertion process as well as the expansion process. That is, multiple components of the intervertebral implant 20 are provided together as a collective single unit so that the collective single unit is inserted into the patient, actuated to allow expansion, and then allowed to remain as a collective single unit in situ. In contrast to other implantable implants requiring insertion of external screws or wedges for expansion, in the present embodiments the actuator does not need to be inserted into the cage, nor removed from the cage, at any stage during the process in some examples. This is because the actuator is manufactured to be captured internal to the implant body, and while freely movable within the cage, are already contained within the implant body so that no additional insertion or removal of the actuator is necessary.

In some embodiments, the implantable implant 20 can be made with a portion of, or entirely of, an engineered cellular structure that includes a network of pores, microstructures and nanostructures to facilitate osteosynthesis. For example, the engineered cellular structure can comprise an interconnected network of pores and other micro and nano sized structures that take on a mesh-like appearance. These engineered cellular structures can be provided by etching or blasting to change the surface of the device on the nano level. One type of etching process may utilize, for example, HF acid treatment. In addition, these cages can also include internal imaging markers that allow the user to properly align the implantable implant 20 and generally facilitate insertion through visualization during navigation. The imaging marker shows up as a solid body amongst the mesh under x-ray, fluoroscopy or CT scan, for example.

Another benefit provided by the implantable implant 20 of the present disclosure is that they are able to be specifically customized to the patient's needs. Customization of the implantable implant 20 is relevant to providing a preferred modulus matching between the implant device and the various qualities and types of bone being treated, such as for example, cortical versus cancellous, apophyseal versus central, and sclerotic versus osteopenic bone, each of which has its own different compression to structural failure data. Likewise, similar data can also be generated for various implant designs, such as for example, porous versus solid, trabecular versus non-trabecular, etc. Such data may be cadaveric, or computer finite element generated. Clinical correlation with, for example, DEXA data can also allow implantable devices to be designed specifically for use with sclerotic, normal, or osteopenic bone. Thus, the ability to provide customized implantable devices such as the ones provided herein allow the matching of the Elastic Modulus of Complex Structures (EMOCS), which enable implantable devices to be engineered to minimize mismatch, mitigate subsidence and optimize healing, thereby providing better clinical outcomes.

Turning now to FIGS. 2A-3C, the intervertebral implant 20 includes an implant body 28 and an actuator 29 that is disposed in the implant body 28. The actuator 29 is configured to drive the implant body 28, and thus the intervertebral implant 20, to expand from the first insertion configuration to the second expanded configuration. The implant body 28, and thus the intervertebral implant 20, defines a distal end 30 and a proximal end 32 opposite the distal end 30. Thus, a distal direction is defined as a direction from the proximal end 32 toward the distal end 30. Conversely, a proximal direction is defined as a direction from the distal end toward the proximal end 32. The distal and proximal directions can be oriented along a longitudinal direction L. The longitudinal direction L can be perpendicular to each of the transverse direction T and the lateral direction A. The distal end 30 defines a leading end with respect to an insertion direction into the intervertebral space, and the proximal end 32 defines a trailing end with respect to the insertion direction into the intervertebral space.

Referring now in particular to FIGS. 2A-2B, the implant body 28 includes a superior body 34 and an inferior body 36 opposite the superior body 34 along the transverse direction T. The superior body 34 defines an exterior superior surface 35 that is configured to face and abut the superior vertebra 24, and the inferior body 36 defines an exterior inferior surface 37 that is configured to face and abut the inferior vertebra 26, respectively. In one example, the superior and inferior bodies 34 and 36 can define projections in the form of teeth, spikes, ridges, or the like, that are configured to grip the superior and inferior bodies 34 and 36 so as to limit or prevent migration of the intervertebral implant 20 in the intervertebral space.

The superior body 34 can be split into a first superior body portion 34 a and a second superior body portion 34 b. The first and second superior body portions 34 a and 34 b can be aligned with each other along the lateral direction A. Further, the first and second superior body portions 34 a and 34 b can be mirror images of each other. The implant body 28 can include an expandable superior mesh portion 38 that extends between the first superior body portion 34 a and the second superior body portion 34 b. For instance, the superior mesh portion 38 can extend from the first superior body portion 34 a to the second superior body portion 34 b. Thus, the superior mesh portion 38 couples the first superior body portion 34 a to the second superior body portion 34 b. The superior mesh portion 38 can extend to the distal end of the implant body 28, or can terminate at a location spaced in the proximal direction from the distal end of the implant body 28. The superior mesh portion 38 can be oriented along the lateral direction A. Therefore, as will be described in more detail below, the superior mesh portion 38 is expandable so as to permit one or both of the first and second superior body portions 34 a and 34 b to move away from the other of the first and second superior body portions 34 a and 34 b as the intervertebral implant 20 expands along the lateral direction A.

The implant body 28 can define a base 40 that is positioned such that the first and second superior body portions 34 a and 34 b extend in the distal direction from the base 40. The base 40 can define the proximal end 32 of the implant body 28, and can further define an aperture that is configured to receive an actuation tool that is configured to apply an actuation force to the actuator 29. The base 40 can be configured as an annular body that extends continuously about the perimeter of the implant body 28. Thus, in one example, the base 40 can lie in a plane that is oriented along the transverse direction T and the lateral direction A. When the intervertebral implant 20 is in the first insertion configuration, the first and second superior body portions 34 a and 34 b can extend parallel to each other. Further, the first and second superior body portions 34 a and 34 b can be spaced from each other by a first distance when the intervertebral implant 20 is in the first insertion configuration. Alternatively, the first and second superior body portions 34 a and 34 b can abut each other when the intervertebral implant 20 is in the first insertion configuration.

The inferior body 36 can be split into a first inferior body portion 36 a and a second inferior body portion 36 b. The first and second inferior body portions 36 a and 36 b can be aligned with each other along the lateral direction A. Further, the first and second inferior body portions 36 a and 36 b can be mirror images of each other. The first inferior body portion 36 a can be aligned with the first superior body portion 34 a along the transverse direction T. Similarly, the second inferior body portion 36 b can be aligned with the second superior body portion 34 b along the transverse direction T. The implant body 28 can include an expandable inferior mesh portion 42 that extends from the first inferior body portion 36 a and the second inferior body portion 36 b. For instance, the inferior mesh portion 42 can extend from the first inferior body portion 36 a to the second inferior body portion 36 b. Thus, the inferior mesh portion 42 couples the first superior body portion 34 a to the second superior body portion 34 b. The inferior mesh portion 42 can further extend in the distal direction from the base 40. The inferior mesh portion 42 can extend to the distal end of the implant body 28, or can terminate at a location spaced in the proximal direction from the distal end of the implant body 28. The inferior mesh portion 42 can be oriented along the lateral direction A. Therefore, as will be described in more detail below, the inferior mesh portion 42 is expandable so as to permit one or both of the first and second inferior body portions 36 a and 36 b to move away from the other of the first and second superior body portions 36 a and 36 b as the intervertebral implant 20 expands along the lateral direction A.

The first and second inferior body portions 36 a and 36 b can extend in the distal direction from the base 40. When the intervertebral implant 20 is in the first insertion configuration, the first and second inferior body portions 36 a and 36 b can extend parallel to each other. Further, the first and second inferior body portions 36 a and 36 b can be spaced from each other by a first distance when the intervertebral implant 20 is in the first insertion configuration. Alternatively, the first and second superior body portions 36 a and 36 b can abut each other when the intervertebral implant 20 is in the first insertion configuration.

The implant body 28 can further include an expandable first side mesh portion 44 that extends between the first superior body portion 34 a to the first inferior body portion 36 a. For instance, the first side mesh portion 44 can extend from the first superior body portion 34 a to the first inferior body portion 36 a. Thus, the first side mesh portion 44 couples the first superior body portion 34 a to the first superior body portion 34 a. The first side mesh portion 44 can further extend in the distal direction from the base 40. The first side mesh portion 44 can extend to the distal end of the implant body 28, or can terminate at a location spaced in the proximal direction from the distal end of the implant body 28. The first side mesh portion 44 can be oriented generally in the transverse direction T. Therefore, as will be described in more detail below, the first side mesh portion 44 is expandable along the transverse direction T so as to permit one or both of the first superior body portion 34 a and the first inferior body portion 36 a to move away from the other of the first superior body portion 34 a and the first inferior body portion 36 a as the intervertebral implant 20 expands along the transverse direction T.

The implant body 28 can further include an expandable second side mesh portion 46 that extends between the second superior body portion 34 b to the second inferior body portion 36 b. For instance, the second side mesh portion 46 can extend from the second superior body portion 34 b to the second inferior body portion 36 b. Thus, the second side mesh portion 46 couples the second superior body portion 34 b to the second superior body portion 34 b. The second side mesh portion 46 can further extend in the distal direction from the base 40. The second side mesh portion 46 can extend to the distal end of the implant body 28, or can terminate at a location spaced in the proximal direction from the distal end of the implant body 28. The second side mesh portion 46 can be oriented generally in the transverse direction T. Thus, as will be described in more detail below, the second side mesh portion 46 is expandable along the transverse direction so as to permit one or both of the second superior body portion 34 b and the second inferior body portion 36 b to move away from the other of the first superior body portion 34 b and the first inferior body portion 36 b as the intervertebral implant 20 expands along the transverse direction T.

In one example, the implant body 28 can be configured such that the base 40 in combination with the first and second superior body portions 34 a-34 b and the first and second inferior body portions 36 a-36 b define a frame 48. The implant body 28 can thus include the frame 48 and the mesh portions 38, 42, 44, and 46 that each can extend in the distal direction from the base 40. The first and second superior body portions 34 a-34 b and the first and second inferior body portions 36 a-36 b can be configured as arms that extend out from the frame 48 in the distal direction. Further, the first and second superior body portions 34 a-34 b and the first and second inferior body portions 36 a-36 b can define respective corners of an outer perimeter of the implant body in a plane that is oriented along each of the transverse direction T and the lateral direction A.

As shown, the first and second superior body portions 34 a and 34 b can be L-shaped in a plane that is oriented along the transverse direction T and the lateral direction A. That is, the first and second superior body portions 34 a and 34 b can each have a first region that extends laterally so as to define the exterior superior surface 35, and a second region that extends inferiorly toward the first and second inferior body portions 36 a and 36 b, respectively. Similarly, the first and second inferior body portions 36 a and 36 b can be L-shaped in the plane that is oriented along the transverse direction T and the lateral direction A. That is, the first and second inferior body portions 36 a and 36 b can each have a respective first region that extends laterally so as to define the exterior inferior surface 37, and a second region that extends superiorly toward the first and second superior body portions 36 a and 36 b, respectively.

Thus, the superior mesh portion 38 can extend from the first region of the first superior body portion 34 a to the first region of the second superior body portion 34 b. The inferior mesh portion can extend from the first region of the first inferior body portion 36 a to the first region of the second inferior body portion 36 b. The first side mesh portion 44 can extend from the second region of the first superior body portion 34 a to the second region of the first inferior body portion 36 a. The second side mesh portion 46 can extend from the second region of the second superior body portion 36 a to the second region of the second inferior body portion 36 b. It is recognized that any one or more up to all of the mesh portions can be interrupted by one or more additional superior body portions, inferior body portions, or side body portions.

The second regions of the first superior body portion 34 a and the first inferior body portion 36 a can define respective first and second portions of a first side wall 50 of the implant body 28. The second regions of the second superior body portion 34 b and the second inferior body portion 36 b can define respective first and second portions of a second side wall 52 of the implant body 28. Thus, the first and second portions of the first and second side walls 50 and 52, respectively are continuous with the first regions of the first and second superior body portions 34 a and 34 b, and the first and second inferior body portions 36 a and 36 b, respectively, along a respective plane that is oriented along the transverse direction T and the lateral direction A in one example. In other examples, the first and second portions of the first and second side walls 50 and 52, respectively, can be spaced from the first and second superior body portions 34 a and 34 b, and the first and second inferior body portions 36 a and 36 b, respectively, along the respective plane that is oriented along the transverse direction T and the lateral direction A.

The first and second superior body portions 34 a and 34 b and the first and second inferior body portions 36 a and 36 b can extend in the distal direction from the base 40. When the intervertebral implant 20 is in the first insertion configuration, the first and second inferior body portions 36 a and 36 b can extend parallel to each other. Further, the first and second inferior body portions 36 a and 36 b can be spaced from each other by a first distance when the intervertebral implant 20 is in the first insertion configuration. Alternatively, the first and second superior body portions 36 a and 36 b can abut each other when the intervertebral implant 20 is in the first insertion configuration. Similarly, the first superior body portion 34 a and the first inferior body portion 36 a can extend parallel to each other. Further, the first superior body portion 34 a and the first inferior body portion 36 a can be spaced from each other, for instance by the first distance, when the intervertebral implant 20 is in the first insertion configuration. Alternatively, the first superior body portion 34 a and the first inferior body portion 36 a can abut each other when the intervertebral implant 20 is in the first insertion configuration. Similarly still, the second superior body portion 34 b and the second inferior body portion 36 b can extend parallel to each other. Further, the second superior body portion 34 b and the second inferior body portion 36 b can be spaced from each other, for instance by the first distance, when the intervertebral implant 20 is in the first insertion configuration. Alternatively, the second superior body portion 34 b and the second inferior body portion 36 b can abut each other when the intervertebral implant 20 is in the first insertion configuration.

The distal end 30 of the implant body 28 can be tapered so as to facilitate insertion of the intervertebral implant 20 into the intervertebral space. That is, each of the first and second superior body portions 34 a-34 b and the first and second inferior body portions 36 a and 36 b can be tapered toward at least one or more up to all of the other of the first and second superior body portions 34 a-34 b and the first and second inferior body portions 36 a and 36 b at the distal end 30 of the implant body 28.

Referring now to FIGS. 3A-3C, the implant body 28 is configured to support the actuator 29 in an actuation cavity 50 of the implant body 28. In particular, the actuator 29 can be disposed in the actuation cavity 50 as-manufactured in an additive manufacturing process. Thus, the actuator 29 need not be separately inserted into the actuation cavity 50 in one example. Further, the actuator 29 can be dimensioned such that it is not able to be inserted into the actuation cavity. It should be appreciated, however, that the present disclosure is not limited to additively manufacturing the intervertebral implant 20 unless otherwise indicated.

The actuator 29 can include a shaft portion 53 and an enlarged head 54 that extends out from the shaft portion 53 along the transverse direction T and the lateral direction A. For instance, the enlarged head 54 can extend out from the shaft portion 53 along the transverse direction T both superiorly and inferiorly, and can further extend out from the shaft portion 53 in opposite lateral directions A. The enlarged head 54 defines first and second lateral expansion surfaces 55 and first and second transverse expansion surfaces 57. The enlarged head 54 can extend out from a distal terminal end of the shaft portion 53. The implant body 28 can guide the actuator 29 to translate along the longitudinal direction L in the actuation cavity upon application of an actuation force to the actuator 29 along the longitudinal direction L. For instance, the implant body 28 can include one or more guide arms 33 that are oriented along the longitudinal direction L and are received in a slot 31 of the actuator 29, thereby guiding the actuator 29 to translate along the longitudinal direction L. As will be described in more detail below, the enlarged head 54 is configured to urge the implant body 28 to expand along the first and second directions of expansion. While the enlarged head 54 defines the lateral and transverse expansion surfaces 55 and 57 in one example, it should be appreciated that any portion of the actuator 29 can alternatively define the lateral and transverse expansion surfaces 55 and 57, such as the shaft portion 53 of the actuator 29.

The implant body 28 can define first and second inner side surfaces 56 and 58 that are spaced from each other along the lateral direction A. The inner side surfaces 56 and 58 can be ramped so as to extend along the lateral direction A as they extend along the longitudinal direction L. That is, each of the first and second inner side surfaces 56 and 58 can include respective first and second ramped inner side surfaces 60 and 62 at a lateral expansion region 59 of the implant body 62. The first and second ramped side surfaces 60 and 62 each taper inward toward the other of the first and second inner side surfaces 56 and 58 as they extend in the distal direction. The first and second ramped side surfaces 60 can be mirror images of each other with respect to a midplane that is oriented along the longitudinal direction L and the transverse direction T. Thus, the first and second ramped side surfaces 60 and 62 can define equal and opposite slopes in one example. Further, the first and second ramped side surfaces 60 and 62 can be aligned with each other along the lateral direction A. Alternatively, the slopes of the first and second ramped side surfaces 60 and 62 can be different than each other. The first ramped side surface 60 can be defined by both the first superior body portion 34 a and the first inferior body portion 36 a. Similarly, the second ramped side surface 62 can be defined by both the second superior body portion 34 b and the second inferior body portion 36 b.

The implant body 28 can define an inner superior surface 64 and an inner inferior surface 66 that are spaced from each other along the transverse direction T. The inner superior surface 64 and the inner inferior surface 66 can be ramped along the transverse direction T as they extend along the longitudinal direction L at a transverse expansion region 61 of the implant body 28. That is, the inner superior surface 64 defines a superior ramped surface 65, and the inner inferior surface 66 defines an inferior ramped surface 67. The ramped surfaces 65 and 67 each taper inward toward the other of the inner superior surface 64 and the inner inferior surface 66 as they extend in the distal direction. The superior ramped surface 65 and the inferior ramped surface 67 can define equal and opposite slopes in one example. Alternatively, the slopes of the superior and inferior ramped surfaces 65 and 67 can be different than each other.

One or both of the ramped surfaces 65 and 67 can be stepped. Thus, the ramped surfaces 65 and 67 can include ramped surface segments 68 and risers 70 disposed between adjacent ramped surface segments 68. The risers 70 can have a slope greater than that of the ramped surface segments 68. Further, each of the risers 70 the superior ramped surface 65 can have the same slope, and each of the risers 70 of the inferior ramped surface 67 can have the same slope. The risers 70 of the superior ramped surface 65 and of the inferior ramped surface 67 can have the same slope as each other. The risers 70 can have a length along the longitudinal direction L that is less than the length of the ramped surface segments 68 along the longitudinal direction L.

The ramped surfaces 65 and 67 can be mirror images of each other about a midplane that is oriented along the longitudinal direction L and the lateral direction T. Thus, each of the ramped surface segments 68 of the superior ramped surface 65 can have the same slope, and each of the ramped surface segments 68 of the inferior ramped surface 67 can have the same slope. Further, the ramped surface segments 68 of the superior ramped surface 65 and the ramped surface segments 68 of the inferior ramped surface 67 can have the same slope as each other. The ramped surfaces 65 and 67 can be aligned with each other along the transverse direction T, such that the ramped surface segments 68 of the ramped surfaces 65 and 67 can be aligned with each other along the transverse direction T, and the risers 70 of the ramped surfaces 65 and 67 can be aligned with each other along the transverse direction T.

With continuing reference to FIG. 3C, the actuator 29 can define at least one actuator ratchet tooth 72 such as a plurality of actuator ratchet teeth 72. The actuator ratchet teeth 72 can be on one side of the actuator 29 or on opposed sides of the actuator 29. In one example, the actuator 29 includes first and second rows of actuator ratchet teeth 72 that are oriented along the longitudinal direction. The first and second rows of actuator ratchet teeth 72 can be opposite each other along the transverse direction T. Alternatively, the first and second rows of actuator ratchet teeth 72 can be opposite each other along the lateral direction A. Alternatively still, the actuator ratchet teeth 72 can have a length that extends about the actuator 29 a distance sufficient to define first and second portions at locations of the actuator 29 that are opposite each other. The actuator ratchet teeth 72 can be disposed on the shaft portion 53 of the actuator 29, but can be alternatively disposed as desired.

The implant body 28 can further define at least one implant ratchet tooth 74 that is configured to interlock with the at least one actuator ratchet tooth 72. The ratchet teeth 72 and 74 are configured to interlock so as to resist movement of the actuator 29 both in an expansion direction that causes the implant body 28 to iterate from the first insertion configuration toward the second expanded configuration, and in a contraction direction that causes the implant body to iterate from the second expanded configuration toward the first insertion configuration. In one example, the implant body 28 can include first and second rows of at least one implant ratchet tooth 74. The first and second rows of the at least one implant ratchet tooth can be aligned with the first and second rows of the at least one actuator tooth 72. Thus, the first and second rows of at least one implant ratchet tooth can interlock with first and second rows of at least one actuator ratchet tooth 72.

Further, the at least one actuator ratchet tooth 72 and the at least one implant ratchet tooth 74 can cam over each other as the actuator 29 is translated with respect to the implant body 28 along the longitudinal direction L. For instance, at least one or both of the at least one actuator ratchet tooth 72 and the at least one implant ratchet tooth 74 is displaceable away from the other of the at least one actuator ratchet tooth 72 and the at least one implant ratchet tooth 74.

In one example, the implant body 28 includes at least one flexible arm 76 that carries the at least one implant ratchet tooth 74. The at least one implant ratchet tooth 74 can be a single ratchet tooth 74 as illustrated, or a plurality of ratchet teeth 74. For instance, the implant body 28 includes first and second flexible arms 76 that each carry at least one implant ratchet tooth 74. Further, the at least one actuator tooth 72 is configured as a plurality of actuator teeth 72. As the actuator 29 is translated along the distal direction and the proximal direction, selectively, the at least one implant ratchet tooth cams 74 over the actuator teeth 72 as the flexible arm 76 resiliently deflects away from the actuator teeth 72. When the at least one implant ratchet tooth 74 is disposed between adjacent ones of the actuator teeth 72, the teeth 72 and 74 define a mechanical interference with each other to prevent inadvertent movement of the actuator 29. The mechanical interference can be overcome by application of an actuation force to the actuator 29 along the longitudinal direction. The actuator 29 can be guided to translate in the implant body 28 such that the actuator ratchet teeth 72 are aligned with the implant ratchet teeth 74 along the longitudinal direction L. That is, the implant body 28 can prevent the actuator 29 from rotating with respect to the implant body an amount that would bring the actuator teeth 72 out of longitudinal alignment with the implant ratchet teeth.

While each of the arms 76 carry a single implant ratchet tooth 74 and the actuator 29 carries a plurality of actuator ratchet teeth 72 in the illustrated example, other configurations are envisioned. For instance, each row of the implant body 28 can alternatively include a plurality of implant ratchet teeth 74 that are configured to intermesh with the at least one actuator ratchet tooth 72. Further, each row of the actuator 29 can include a single actuator ratchet tooth 72 or a plurality of actuator ratchet teeth 72. Further still, the actuator ratchet teeth 72 can be disposed on deflectable actuator arms if desired.

In still another example, referring to FIGS. 6A-6B, the actuator 29 can be rotatable about its central longitudinal axis. Thus, when the actuator is in a first rotational position, the actuator ratchet teeth 72 can be out of alignment with the implant ratchet teeth 74 with respect to the longitudinal direction L. Thus, the actuator 29 can be freely translatable in the implant body 28 along the longitudinal direction L without causing the actuator ratchet teeth 72 to mechanically interfere with the implant ratchet teeth 74. Once the actuator 29 has been translated to a desired longitudinal position, the actuator 29 can be rotated to a second rotational position, whereby the at least one implant ratchet tooth 74 is disposed between adjacent ones of the actuator ratchet teeth 72. In one example, the second rotational position can be ninety degrees offset from the first rotational position. Alternatively or additionally, the at least one actuator tooth 72 can be disposed between adjacent ones of a plurality of implant ratchet teeth 74. When the actuator 29 is in the second rotational position, mechanical interference defined by the ratchet teeth 72 and 74 prevent movement of the actuator 29 relative to the implant body 28 along the longitudinal direction L.

Referring now to FIGS. 4A-5C in general, operation of the intervertebral implant 20 will now be described. In particular, the actuator 29 is movable in the implant body 28 from an initial position shown in FIG. 4A to a first expansion position shown in FIG. 4B, and subsequently from the first expansion position to a second expansion position, shown in FIGS. 5B-5C. Movement of the actuator 29 from the initial position to the first expansion position causes the actuator 29 to urge the implant body 28 to expand along a first direction of expansion from the first configuration shown in FIG. 4A to the first expansion shown in FIG. 4B. Movement of the actuator 29 from the first expansion position to the second expansion position causes the actuator 29 to urge the implant body 28 to expand along the second direction of expansion that is perpendicular to the first direction of expansion, as illustrated in FIGS. 5B-5C. In one example, the actuator 29 is translatable in the distal direction from the initial position to the first expansion position, and further from the first expansion position to the second expansion position. For instance, the actuator 29 can translate in the distal direction without undergoing rotation. Alternatively, in an alternative example the actuator 29 can be configured as a screw that rotates as it translates in the distal direction.

Referring now to FIGS. 4A-4B in particular, when the actuator 29 is in the initial position, the implant body 28 is in the first or initial configuration. When the implant body 28 is in the first or initial configuration, the implant body 28 defines a first width along the lateral direction A and a first height along the transverse direction T. Further, when the actuator 29 is in the initial position, the enlarged head 54 can be spaced from the ramped side surfaces 60 and 62 in the proximal direction. Alternatively, the enlarged head 54 can be aligned with the ramped side surfaces 60 and 62 along the lateral direction A. Accordingly, when the actuator 29 is in the initial position, the actuator has not yet urged the implant body to expand along the first direction of expansion, which can be defined by the lateral direction A.

As the actuator 29 is translated in the distal direction from the first or initial position to the first expansion position in the lateral expansion region 59, the lateral expansion surfaces 55 ride along the first and second ramped side surfaces 60 and 62, thereby expanding the implant body 28 along the lateral direction A from the initial configuration to a laterally expanded configuration, which can define the first expansion. The implant body 28 defines a first lateral distance between the proximal ends of the ramped side surfaces 60 and 62 along the lateral direction A, and a second lateral distance between the distal ends of the ramped side surfaces that is less than the first lateral distance. Therefore, as the lateral expansion surfaces 55 ride along the first and second ramped side surfaces 60 and 62, the lateral expansion surface 55 urges the implant body 28 to expand along first direction of expansion to a second width along the lateral direction A that is greater than the first width. The first and second widths can be measured from the outer surface of the first side wall 50 to the outer surface of the second side wall 52.

In particular, each of the superior body 34 and the inferior body 36 can expand along the lateral direction A. For instance, the actuator 29 urges at least one or both of the first superior body portion 34 a and the second superior body portion 34 b (see FIG. 2A) away from the other of the first superior body portion 34 a and the second superior body portion 34 b along the lateral direction A. Further, the actuator 29 urges at least one or both of the first inferior body portion 36 a and the second inferior body portion 36 b (see FIG. 2B) away from the other of the first inferior body portion 36 a and the second inferior body portion 36 b along the lateral direction A. Further still, the actuator 29 can urge either or both of the first side wall 50 and the second side wall 52 away from the other of the first side wall 50 and the second side wall 52. The superior and inferior mesh portions 38 and 42 can expand along the lateral direction A as the implant body 28 expands along the lateral direction A.

While in one example the first and second inner side surfaces 56 and 58 are ramped, it should be appreciated that alternatively or additionally the lateral expansion surfaces 55 can be ramped. That is, the lateral expansion surfaces can be tapered toward each other along the lateral direction A as they extend in the distal direction. Thus, as the actuator 29 moves in the distal direction, the lateral expansion surfaces 55 can urge the implant body 28 to expand along the lateral direction A.

As described above, the first and second superior body portions 34 a-34 b and the first and second inferior body portions 36 a-36 b can each extend distally from the base 40. Thus, as the implant body 28 expands along the first direction of expansion, the first and second superior body portions 34 a-34 b and the first and second inferior body portions 36 a-36 b can flex laterally outward with respect to the base 40. Thus, the width of the implant body 28 along the lateral direction A at the proximal ends of the first and second superior body portions 34 a-34 b and the first and second inferior body portions 36 a-36 b can be less than the width of the implant body 28 along the lateral direction A at the distal ends of the first and second superior body portions 34 a-34 b and the first and second inferior body portions 36 a-36 b.

Referring now also to FIGS. 5A-5C, when the implant body 28 has expanded along the first direction of expansion, the actuator can be further translated along the distal direction from the first expansion position to the second expansion position, thereby expanding the implant to the second or expanded configuration. The second expansion position can be any position that causes the implant body 28 to expand along the second direction of expansion after expansion along the lateral direction A has completed. As will now be described, the second direction of expansion causes at least one or both of the superior and inferior bodies 34 and 36 to move away from the other of the superior and inferior bodies 34 and 36.

When the actuator 29 is in the first expansion position, the implant body 28 has a first height along the transverse direction T. The implant body 28 also has the first height when the actuator 29 is in the initial position and the implant body 28 is in the first or initial configuration. Further, when the actuator 29 is in the first expansion position, the enlarged head 54 can be spaced from the superior ramped surface 65 and the inferior ramped surface 67 along the proximal direction. Alternatively, the enlarged head 54 can be aligned with the superior and inferior ramped surfaces 65 and 67 along the transverse direction T. When the actuator 29 is in the first expansion position, the actuator 29 has not yet urged the implant body 28 to expand along the second direction of expansion, which can be defined by the transverse direction T.

As the actuator 29 is translated in the distal direction from the first expansion position toward the second expansion position, the transverse expansion surfaces 57 ride along the superior ramped surface 65 and the inferior ramped surface 67, thereby urging the implant body 28 to expand along the transverse direction T. The implant body 28 defines a first distance between the proximal ends of the superior and inferior ramped surfaces 65 and 67 along the transverse direction T, and a second transverse distance between the distal ends of the superior and inferior ramped surfaces 65 and 67 that is less than the first transverse distance. Therefore, as the transverse expansion surfaces 57 ride along the superior and inferior ramped surfaces 65 and 67, the transverse expansion surfaces 57 urge the implant body 28 to expand along the transverse direction A to a second height along the transverse direction T that is greater than the first height. In particular, the actuator 29 urges at least one or both of the superior body 34 and the inferior body 36 (see FIG. 2A) away from the other of the superior body 34 and the inferior body 36 along the transverse direction T. The first and second side mesh portions 44 and 46 can expand along the transverse direction as the implant body 28 expands along the transverse direction T. The mesh portions 38, 42, 44, and 46 can be constructed in accordance with any suitable embodiment as desired. In one example, the mesh portions can include a plurality of interconnected links that are movable with respect to each other so as to allow the mesh portions to expand along the respective directions.

As illustrated in FIG. 5C, when the implant 20 has been fully expanded along the second direction of expansion, the superior ramped surface 65 and the inferior ramped surface 67 can transition from the slopes described above to a second orientation that is less angled with respect to the longitudinal direction L. For instance, at least one or more of the superior and inferior ramped surfaces 65 and 67 can be oriented substantially along the longitudinal direction L, such as within +/−five degrees of the longitudinal direction L.

As described above, the superior and inferior bodies 34 and 36 can each extend distally from the base 40. Thus, as the implant body 28 expands along the second direction of expansion, the superior and inferior bodies 34 and 36 can flex outward with respect to the base 40 along the transverse direction T. Thus, the height of the implant body 28 along the transverse direction T at the proximal ends of the superior and inferior bodies 34 and 36 can be less than the height of the implant body 28 along the transverse direction T at the distal ends of the superior and inferior bodies 34 and 36. As a result, expansion of the implant body 28 along the second direction of expansion can change, for instance increase, a lordotic angle defined by the exterior superior surface 35 and the exterior inferior surface 37. Further expansion of the implant body 28 along the second direction of expansion can further change the lordotic angle.

As described above, the ramped surfaces 65 and 67 can include ramped surface segments 68 and risers 70 disposed between adjacent ramped surface segments 68. Thus, as the actuator 29 translates distally the transverse expansion surfaces 57 alternatingly ride along the ramped surface segments 68 and risers 70. The implant body 28 can achieve a fully expanded height when the actuator 29 has translated to a position whereby the actuator 29 can no longer be translated along the distal direction. Further as described above, the implant body 28 and the actuator 29 include respective ratchet teeth 72 and 74 that are configured to engage each other so as to lock the implant body 28 in the second or expanded position. When the ratchet teeth 72 and 74 engage each other, the actuator 29 can be prevented from translating in the proximal direction with respect to the implant body 28. In particular, at least one of the proximal surface of the implant ratchet teeth 74 and the distal surface of the actuator ratchet teeth 72 can be oriented to prevent the ratchet teeth 72 and 74 from camming over each other in the proximal direction. Thus, the actuator 29 can be prevented from translating in the proximal direction with respect to the implant body 28.

As a result, the actuator 29 can be translated in the distal direction to a position whereby the transverse expansion surfaces 57 are engaged with the respective ramped surfaces 65 and 67. The engagement of the ratchet teeth 72 and 74 can prevent the actuator 29 from translating in the proximal direction, which would cause the implant to collapse along the transverse direction T. Thus, the implant can be expanded to a position to a height along the transverse direction T that is less than the fully expanded height. Further, the ratchet teeth 72 and 74 can engage when the actuator 29 is in the first expansion position. Thus, the implant 28 can be locked in the laterally expanded configuration so as to prevent contraction of the implant 28 along the lateral direction A without expanding along the transverse direction T. Further, the implant 28 can be locked in the laterally expanded configuration and in a transverse expanded configuration having an expanded height less than the fully expanded height. Accordingly, expansion of the implant 20 along the transverse direction T can be controlled after the implant 20 has been fully expanded along the lateral direction A.

The first and second inner side surfaces 56 and 58 at the transverse expansion region 61 can be oriented along respective planes that are defined by the transverse direction T and the longitudinal direction L when the implant 20 has achieved the first expansion. Thus, as the lateral expansion surfaces 55 ride along the first and second inner side surfaces 56 and 58 as the actuator translates in the distal translation of the actuator 29 in the transverse expansion region 61, the lateral expansion surfaces 55 do not urge the implant body 28 to expand along the lateral direction A. Accordingly, distal translation of the actuator head 54 in the transverse expansion region 61 causes the implant to expand along the transverse direction T without expanding along the lateral direction A. Alternatively, the first and second inner side surfaces 56 and 68 can be sloped inwardly toward each other along the lateral direction A as they extend in the distal direction. Thus, distal translation of the actuator 29 in the transverse expansion region 61 can cause the lateral expansion surfaces 55 of the actuator 29 urge the implant body 28 to further expand along the lateral direction A. In one example, the slope of the first and second inner side surfaces 56 and 68 can be less than the slope of the ramped inner side surfaces 60 and 62.

While in one example the superior and inferior surfaces 64 and 66, respectively, are ramped, it should be appreciated that alternatively or additionally the transverse expansion surfaces 57 can be ramped. That is, transverse expansion surfaces 57 can be tapered toward each other along the transverse direction T as they extend in the distal direction. Thus, as the actuator 29 moves in the distal direction, the transverse expansion surfaces 57 can urge the implant body 28 to expand along the lateral direction T.

As described above, at least a portion up to an entirety of the transverse expansion region 61 can be disposed distal of the lateral expansion region 59. Thus, at least respective portions up to respective entireties of the superior and inferior ramped surfaces 65 and 67 can be disposed distal of the ramped side surfaces 60 and 62. Accordingly, in one example, movement of the actuator 29 from the initial position to the first expansion position does not urge the implant body 28 to expand along the second direction of expansion. Alternatively, a portion of the vertical expansion region 61 can partially overlap the lateral expansion region 59. Accordingly, the implant body 28 can further expand along the lateral direction A as it expands along the transverse direction T. In both examples, at least a portion of the vertical expansion region 61 extends distal of the lateral expansion region 59, and the implant is expandable along the transverse direction T without expanding along the lateral direction A.

As described above, the first direction of expansion can be along the lateral direction A, and the second direction of expansion can be along the transverse direction T. Alternatively, the first direction of expansion can be along the transverse direction T, and the second direction of expansion can be along the lateral direction A. In this regard, at least a portion of the lateral expansion region 59 can be disposed distal of the transverse expansion region 61.

It should be appreciated that the illustrations and discussions of the embodiments shown in the figures are for exemplary purposes only, and should not be construed limiting the disclosure. One skilled in the art will appreciate that the present disclosure contemplates various embodiments. Additionally, it should be understood that the concepts described above with the above-described embodiments may be employed alone or in combination with any of the other embodiments described above. It should be further appreciated that the various alternative embodiments described above with respect to one illustrated embodiment can apply to all embodiments as described herein, unless otherwise indicated. 

What is claimed is:
 1. An intervertebral implant comprising: an implant body defining a superior body configured to face a superior vertebra and an inferior body configured to face an inferior vertebra; and an actuator supported by the implant body, the actuator movable in the implant body from an initial position to a first expansion position, and subsequently from the first expansion position to a second expansion position, wherein movement of the actuator from the initial position to the first expansion position causes the actuator to urge the implant body to expand along a first direction of expansion, and movement of the actuator from the first expansion position to the second expansion position causes the actuator to urge the implant body to expand along a second direction of expansion that is perpendicular to the first direction of expansion.
 2. A method for implanting an intervertebral implant, the method comprising the steps of: inserting the intervertebral implant into an intervertebral space, such that a superior body of the intervertebral endplate faces a superior vertebra, and an inferior body of the intervertebral implant faces an inferior vertebra; moving an actuator of the implant from an initial position to a first expansion position, such that the actuator urges the implant body to expand along a first direction of expansion; and subsequently moving the actuator from the first expansion position to a second expansion position, such that the actuator urges the implant body to expand along a second direction of expansion that is perpendicular to the first direction of expansion. 